The Recall Desk
SevereFDA (Devices)·Z-2208-2012·Announced 2012-08-22

Philips Easy Diagnost Classic x-ray system recall for switch defect

Philips Healthcare Inc. is recalling 12 Easy Diagnost Classic stationary x-ray systems because an incorrectly mounted inclination switch may fail to stop table tilting.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a medical device that could lead to significant injury if the table tilts uncontrollably.

Plain-English summary

Philips Healthcare Inc. is recalling 12 units of the Easy Diagnost Classic stationary x-ray system (Catalog Numbers: 70642, 70643, 706030, 706031, 706032). The recall involves specific serial numbers: SN07000141, SN07000109, SN5000162, SN5000421, SN07000667, 200148, 200115, 200081, and 300114.

The recall is due to a defect where the inclination switch in the stand may have been mounted incorrectly. As a result, the switch could fail to stop the tilting movement of the table base due to hardware or software errors.

The affected units were distributed worldwide, including in the United States (IN, MA, MI, MO, NC, NY, PA, SC, and WI) and in Canada, Hong Kong, and New Zealand. Users should contact Philips Healthcare Inc. for instructions on how to address this issue.

The recalled product

Product
Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642, 70643, 706030, 706031, 706032 Stationary x-ray system, Universal RF system for general use.
Affected units
12

Distribution

Distributed in 6 states: